Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01504048

Enrollment

150

Registered

2012-01-05

Start date

2009-06-30

Completion date

2016-12-31

Last updated

2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diarrhoea, Collagenous Colitis, Lymphocytic Colitis

Keywords

Microscopic colitis, Intestinal Diseases, Inflammatory Bowel Diseases

Brief summary

The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.

Detailed description

Microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. Obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. Chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (Suzuki 2011). The aim of this study is to investigate if chromoendoscopy using Indigo-Carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.

Interventions

PROCEDUREColonoscopy with Indigo-Carmine Chromoendoscopy

Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in five areas of the large intestine: Cecum, ascending colon, transverse colon, descending colon and rectum. Pictures are taken before and after dye-spraying and biopsies are collected from all segments of the large intestine and rectum.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with chronic non-bloody diarrhea for at least one month

Exclusion criteria

* Patients who decline to participate * Unable to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
Detection of microscopic colitis using chromoendoscopy	12 month	To investigate the usefullness of chromoendoscopy in diagnosing microscopic colitis using 0.2-0.5% Indigo-Carmine dye spray. The golden standard is the results of histological examination of biopsies from the colo-rectal mucosa.

Countries

Sweden

Contacts

Primary ContactPeter T Schmidt, MD, PhD

peter.thelin.schmidt@ki.se+46 8 51770000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026